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An Interactive Education Program to Reduce High Risk Behavior in Adolescents Ph II (iTRAC HERO)

An Interactive Education Program to Reduce High Risk Behavior in Adolescents Ph II

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06894277
Acronym
iTRAC-HERO
Enrollment
120
Registered
2025-03-25
Start date
2025-04-01
Completion date
2026-08-31
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, Emotion Regulation, Risky Sexual Behavior

Keywords

Risky Sexual Behavior, Emotion Regulation, Adolescent Behavior

Brief summary

Using the efficacious iTRAC intervention to enhance emotion regulation competencies as a foundation, this study will create and test iTRAC-HERO to teach emotion regulation skills in the context of sexual health education.

Detailed description

Adolescence is a critical developmental period during which behavioral patterns are formed that have powerful influences on current and future health. This is particularly true for sexual behavior, which is affected by the biological changes of puberty as well as normative developmental tasks around sexual exploration. Engaging in sexual behavior in early adolescence (before age 15) is associated with more partners, less condom use, and more frequent sex as teens get older, and these factors increase risk for negative health outcomes (e.g., sexually transmitted infections and unplanned pregnancy) throughout their lives. Many sexual health interventions teach prevention skills, such as assertiveness or condom use; the premise of the current application is that these skills are often unused by adolescents because of deficits in emotion regulation (ER), which is unaddressed in most sexual health education. Our research team has developed and tested a novel, engaging, efficacious, and developmentally tailored group intervention (Project TRAC) to teach ER skills to early adolescents within the context of sexual health. A study of Project TRAC showed that participants taught ER skills were less likely to start having sex over the 2.5 year follow up. While efficacious, the small group format of the Adolescence is a critical developmental period during which behavioral patterns are formed that have powerful influences on current and future health. This is particularly true for sexual behavior, which is affected by the biological changes of puberty as well as normative developmental tasks around sexual exploration. Engaging in sexual behavior in early adolescence (before age 15) is associated with more partners, less condom use, and more frequent sex as teens get older, and these factors increase risk for negative health outcomes (e.g., sexually transmitted infections and unplanned pregnancy) throughout their lives. Many sexual health interventions teach prevention skills, such as assertiveness or condom use; the premise of the current trial is that these skills are often unused by adolescents because of deficits in emotion regulation (ER), which is un-addressed in most sexual health education. The research team has developed and tested a novel, engaging, efficacious, and developmentally tailored group intervention (Project TRAC) to teach ER skills to early adolescents within the context of sexual health. A study of Project TRAC showed that participants taught ER skills were less likely to start having sex over the 2.5 year follow up. While efficacious, the small group format of the program presents barriers to sustainability and dissemination; significant advantages of web-based delivery exist. To explore whether the ER concepts of TRAC could be taught in a web-based format, the investigators completed a pilot study to translate TRAC's ER content to a web-based intervention (iTRAC), using Designing for Dissemination principles that enhance the likelihood of successful dissemination upon completion. iTRAC demonstrated feasibility and acceptability, and a randomized trial showed that iTRAC participants reported significantly better emotional competence compared to waitlist control participants. This study will complete the technology adaptation of the program to include its sexual health content and content linking ER to sexual health. This phase will create iTRAC-HERO as a web app. Once completed, acceptability testing will be completed with early adolescents to allow for modifications based on participant feedback. Once finalized, a small RCT will assess impact on adolescents' self-efficacy for preventing sexual risk as well as engagement in sexual behaviors.

Interventions

BEHAVIORALiTRAC-HERO

iTRAC-HERO will consist of eight, approximately 45-minute, "gamified" digital modules of 4-6 activities (games, videos, etc.). No instruction is needed to use the program. Content will use gender- and sexuality-inclusive language and avoid heteronormative descriptions of risk. This content will include strategies for (and practice with) recognizing and managing emotions, particularly in relation to sexual health situations, to enhance the likelihood that the emotion regulation and sexual health education provided can be applied to experiences that are emotionally arousing and lead to risk.

Sponsors

Klein Buendel, Inc.
Lead SponsorINDUSTRY
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Rhode Island Hospital
CollaboratorOTHER
University of Oregon
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Waitlist Control Trial

Eligibility

Sex/Gender
ALL
Age
12 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

* Attending 7th grade * Between 12 and 14 years old * Parent/guardian speaks English or Spanish * Attending participating school

Exclusion criteria

* Unable to read at a 4th grade level * Have a sibling who has participated in the study * Have a development disorder

Design outcomes

Primary

MeasureTime frameDescription
Change in Sexual Self-Efficacy (SSE) from baseline to 6 months.Baseline, 1 month post-intervention, 6 month follow upThe Sexual Self-Efficacy Scale (12 items) will measure self-efficacy for safer sexual activity as a main outcome which will indicate iTRAC-HERO's efficacy and ability to promote healthier sexual behaviors with the full sample (not just those who are sexually active).
Change in Self Efficacy for HIV Prevention from baseline to 6 month.Baseline, 1 month post-intervention, 6 month follow upThe Self-Efficacy for HIV Prevention Scale (12 items) assesses a range of behaviors related to prevention of HIV, other STIs, or unintended pregnancy, including refusing sexual behaviors, discussing sexual histories with partners, buying condoms, taking free condoms, carrying condoms, and asking a partner to use a condom.

Secondary

MeasureTime frameDescription
Change in Sexual Risk Cognition from baseline to 6 monthsBaseline, 1 month post-intervention, 6 month follow upThe Sexuality Questionnaire for Adolescents (34 items) is a multiple choice test to assess sexual health knowledge and has been shown to be sensitive to intervention impact.
Change in attitudes towards abstinence from baseline to 6 monthsBaseline, 1 month post-intervention, 6 month follow upThe Abstinence Attitudes questionnaire assesses agreement with values related to abstinence (α= .86).
Change in frequency of sexual and substance use behaviors from baseline to 6 monthsBaseline, 1 month post-intervention, 6 month follow upThe Adolescent Risk Behavior Assessment (ARBA) will assess sexual behavior, including behaviors relevant to this developmental period.
Change in adolescent substance use behaviors from baseline to 6 monthsBaseline, 1 month post-intervention, 6 month follow upYouth Risk Behavior Surveillance System items will be used to assess tobacco/vape use, violence (e.g., fighting), and substance use behaviors.

Countries

United States

Contacts

CONTACTJulia Berteletti
jberteletti@kleinbuendel.com3035654321
PRINCIPAL_INVESTIGATORChristopher Houck, PhD

Rhode Island Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026